Status:
COMPLETED
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Conditions:
Irritable Bowel Syndrome With Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
Eligibility Criteria
Inclusion
- Must not be pregnant or breastfeeding and agree to use birth control;
- Completion of a negative colonoscopy as per American Gastroenterology Association (AGA) criteria and no clinically-significant laboratory or physical examination findings;
- Meets protocol-defined criteria for IBS-C, including stool frequency, straining, stool consistency, abdominal pain, and abdominal discomfort criteria;
- Demonstrates English fluency and has access to a touch-tone telephone.
Exclusion
- Recent history of mushy or watery stools;
- Various medical conditions, medical histories, or family medical histories that would not make the patient a good candidate for the study;
- Clinically-significant alarm symptoms;
- Secondary causes of constipation or evacuation disorders;
- Surgery to the gastrointestinal tract;
- Usage of prohibited medications.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00460811
Start Date
April 1 2007
End Date
April 1 2008
Last Update
February 4 2013
Active Locations (85)
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Microbia Investigational Site
Huntsville, Alabama, United States, 35801
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Chandler, Arizona, United States
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Tuscon, Arizona, United States
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Microbia Investigational Site
Sherwood, Arkansas, United States